| CTRI Number |
CTRI/2024/12/078611 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Estimation of frailty in adult male paients |
|
Scientific Title of Study
|
Pilot study for estimation of prevalence of frailty in adult male patients in different age groups scheduled for elective
surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nikita D Chikate |
| Designation |
Resident |
| Affiliation |
INHS ASVINI |
| Address |
Department of Anaesthesiology, INHS ASVINI, near RC Church, Colaba, Mumbai
Mumbai
MAHARASHTRA
400005
India |
| Phone |
7620020670 |
| Fax |
|
| Email |
chikatenikita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidhu Bhatnagar |
| Designation |
Professor |
| Affiliation |
INHS ASVINI |
| Address |
Department of Anaesthesiology, INHS ASVINI, Near RC Church, Colaba, MUmbai
MAHARASHTRA
400005
India |
| Phone |
9969777168 |
| Fax |
|
| Email |
vizardvids@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikita D Chikate |
| Designation |
Resident |
| Affiliation |
INHS ASVINI |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, INHS ASVINI, NEAR RC CHURCH, COLABA, MUMBAI
MAHARASHTRA
400005
India |
| Phone |
7620020670 |
| Fax |
|
| Email |
chikatenikita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, INHS ASVINI, Colaba, Mumbai, Maharashtra-400005 |
|
|
Primary Sponsor
|
| Name |
Dr NIkita D Chikate |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, INHS ASVINI, COLABA, MUMBAI-400005 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR NIKITA D CHIKATE |
INHS ASVINI |
DEPARTMENT OF ANAESTHESIOLOGY, INHS ASVINI, NEAR RC CHURCH, COLABA, MUMBAI
Mumbai
MAHARASHTRA |
07620020670
chikatenikita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INHS ASVINI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Male |
| Details |
(i) All patients of age more than or equal to 18 yrs coming for elective surgery and consenting to be in
study
(ii) ASA grade I – II |
|
| ExclusionCriteria |
| Details |
(i) Patients refusing to consent for the study
(ii) Patient with cardio-respiratory problems
(iii) Patients with Chronic Renal Disease, chronic
liver disease, immunocompromised patients
(iv) Patient with psychiatric disease
(v) All patients having muscular dystrophy
and/or muscle atrophy due to any structural
or physiological problem
(vi) ASA Grade III and above |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of frailty in adult male patients |
before start of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relation of BMI, USG guided measurement of Muscle Thickness, Serum Albumin and Clinical Frailty Score |
Before start of Surgery |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Protocol as follows: -
(a) Written and informed consent will be obtained from
all the patients to be included in the study. Ethical
committee clearance would be taken from the institutional
ethical committee.
(b) The clinical trial registration would be
accomplished. Patients fulfilling the inclusion criteria and
giving the written and informed consent will be explained
about the procedure and Clinical Frailty Scale.
(c) Pre-Anaesthetic checkup will be done on OPD
basis.
(d) Anaesthesia PGT1 will get the Clinical Frailty Scale
Questionnaire filled by the patients on day prior to surgery
during pre-anaesthesia visit. Anaesthesia PGT1 will
remain same for all 200 patients and will be blinded to the
readings of Anaesthesia PGT2, who will be responsible for
measuring muscle thickness by USG.
(e) Day prior to surgery, Anaesthesia PGT2 will record
Ultrasonographic Measurements of Rectus Femoris,
Vastus Intermedius and Triceps muscles. Anaesthesia
PGT2 has done 100 such scans under consultant
guidance. Anaesthesia PGT2 will be same for all the 200
patients and will be blinded to the Clinical Frailty Scale.
This will be done to minimise observer bias. Using Bedside
Ultrasound Machine, muscle thickness of each patient will
be measured. For this, thickness of following 2 muscles will
be measured by Anaesthesia PGT2: -
(i) Rectus Femoris and Vastus intermedius4-
Patient will be in supine position. After
measuring and marking the mid-point
between greater trochanter and superior
margin of patella, USG probe will be placed
on the anterior portion of thigh. Thickness of
muscle will be measured by ultrasound
callipers starting from subcutaneous tissue to
femur and recorded.
(ii) Triceps- patient will be supine position. Arm
of the patient will be asked to be kept in flexion
such that hand rests over the forehead. In
such way, posterior portion of the arm will
come in front. Now, using ultrasound callipers,
thickness of triceps will be measured at the
level of midline of arm.
(f) Serum Albumin level will be recorded on day prior
to surgery.
(g) After collection of data, results will be analysed. |